NCT02158481

Brief Summary

The main aim of the study is to investigate the effects of dietary ingredients (polyphenols and carotenoids) on vascular function during acute glucose load. Each subject will receive 4 weeks of intervention with test product or placebo product after a dietary restriction run-in period of 14 days. Subjects will be challenged with an oral glucose tolerance test (OGTT) immediately after the run-in phase and at the end of the intervention phase. During the OGTT, blood samples will be taken at regular intervals. The study will be conducted in subjects with impaired glucose tolerance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

8 months

First QC Date

March 24, 2014

Last Update Submit

June 23, 2015

Conditions

Vascular DiseasesImpaired Glucose Tolerance

Keywords

Vascular functionDietary ingredientsAcute glucose loadOxidative stress

Outcome Measures

Primary Outcomes (1)

  • Interleukin-6 (IL-6) levels.

    At baseline (after 2 weeks run-in period) and after 4 weeks intervention

Secondary Outcomes (3)

  • Pro-inflammatory and oxidative stress biomarkers

    At baseline (after 2 weeks run-in period) and after 4 weeks intervention

  • Cell stress-defence responses

    At baseline (after 2 weeks run-in period) and after 4 weeks intervention

  • Clinical chemistry parameters

    At baseline (after run-in period of 2 weeks) and after 4 weeks intervention

Study Arms (2)

Dietary ingredients: polyphenols and carotenoids

ACTIVE COMPARATOR

Dietary ingredients: polyphenols and carotenoids

Dietary Supplement: A capsule containing both polyphenols and carotenoids

Placebo product

PLACEBO COMPARATOR

Placebo product

Dietary Supplement: Placebo intervention

Interventions

A capsule containing both polyphenols and carotenoidsDIETARY_SUPPLEMENT
Dietary ingredients: polyphenols and carotenoids
Placebo interventionDIETARY_SUPPLEMENT

Placebo intervention

Placebo product

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females confirmed with IGT;
  • Age ≥ 35 and ≤ 65 year at screening;
  • Body Mass Index (BMI) \> 25 and \<40 kg/m2;
  • Reported intense sporting activities ≤ 10h/w;
  • Reported alcohol consumption ≤ 14 units/week (female volunteers) or ≤ 21 units/week (male volunteers)
  • Currently not smoking and being a non-smoker for at least six months

You may not qualify if:

  • Any medical condition or use of over-the-counter and prescribed medication which might affect study measurement (judged by the study physician);
  • No reported participation in another nutritional or biomedical trial 3 months before screening;
  • Reported weight loss or gain of 10% or more during a period of 6 months prior to screening;
  • Anti-hyperglycemic drug or other medication which interferes with study measurements;
  • No blood donation 1 month prior to screening;
  • Reported allergy or intolerance to test products or other food products provided during the study;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aspect Clinical

Ledbury, United Kingdom

Location

MeSH Terms

Conditions

Vascular DiseasesGlucose Intolerance

Interventions

Carotenoids

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesHyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Alex Thompson, Dr

    Aspect Clinical

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2014

First Posted

June 6, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 24, 2015

Record last verified: 2015-06

Locations

GB(1)